Breast Cancer
Conditions
Keywords
Breast cancer, breast cancer screening
Brief summary
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
Interventions
DEVICEHologic Selenia Dimensions Digital Breast Tomosynthesis System
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.
Sponsors
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Female * Any ethnic origin * No contraindication of routine bilateral mammography
Exclusion criteria
* Any contraindications to mammographic screening, including but not limited to: * Significant existing breast trauma * Pregnancy * Lactating * Previous surgical biopsy * Previous breast cancer * Placement of an internal breast marker * Breast implants * Unable to understand and execute written informed consent * Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. | At time of exam | ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of ROC Performance in Subjects With Dense Breasts | At time of exam | The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4). Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference. |
| Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | at time of exam | The non-cancer recall rate was measured for 3DS and 2D FFDM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Undergoing Breast Cancer Screening The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy.
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure. | 3,521 |
| Total | 3,521 |
Baseline characteristics
| Characteristic | Subjects Undergoing Breast Cancer Screening |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 521 Participants |
| Age, Categorical Between 18 and 65 years | 3000 Participants |
| Region of Enrollment United States | 3521 participants |
| Sex: Female, Male Female | 3521 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,521 |
| serious Total, serious adverse events | 0 / 3,521 |
Outcome results
Primary
To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
Time frame: At time of exam
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 3D + s2D | To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. | 0.907 Proportion |
| 2D FFDM | To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. | 0.867 Proportion |
Comparison: A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.p-value: 0.009MRMC ROC Analysis
Secondary
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
The non-cancer recall rate was measured for 3DS and 2D FFDM
Time frame: at time of exam
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3D + s2D | Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | 54.6 percentage of recalls |
| 2D FFDM | Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM | 67.2 percentage of recalls |
Secondary
Analysis of ROC Performance in Subjects With Dense Breasts
The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4). Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.
Time frame: At time of exam
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 3D + s2D | Analysis of ROC Performance in Subjects With Dense Breasts | 0.893 Proportion |
| 2D FFDM | Analysis of ROC Performance in Subjects With Dense Breasts | 0.848 Proportion |
p-value: 0.045MRMC ROC Analysis